Health in Work - a Measure for Increased Coping and Work Inclusion - An Analysis of Effect of Preventive Information Given at the Workplace - Part 1: Quantitative Data Collection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,383
- 试验地点
- 1
- 主要终点
- Change in overall sickness absence rates (self- and physician-certified) at the workplace (unit level)
研究概览
简要总结
Health in work - a measure for increased coping and work participation
-An effect analysis of a health- and work environment intervention at the workplace. Part 1:quantitative data collection
The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national programme Health in work (HelseIArbeid) through a pragmatic cluster-randomized study.
The main hypothesis is that this interdisciplinary health and welfare intervention at the workplace reduces sick leave and improves mastering of common health problems more efficiently than a conventional welfare intervention. More specifically, it is hypothesized that the Health in work intervention has a better cost-effectiveness in terms of sick leave, use of health services and coping with common health problems indicated by an increased health-related quality of life.
详细描述
The main objective of this study is to investigate the effect of the workplace intervention in the new Norwegian national concept Health in work (HelseIArbeid) through a pragmatic cluster-randomized study.
The interdisciplinary Health in work intervention consists of three information sessions over the course of one year, with work place processes in between. In the meetings, structured health information about musculoskeletal- and mental disorders is given and put in the context of working and the specific workplace. This includes possibilities to work despite health impairment, work inclusion measures, and discussion on how these could have an influence on the individual, group, management and organizational level. The process involves the workplaces' entire staff (employers and employees). It is an active process and workplaces are stimulated and expected to continue to work with these topics both between sessions and after the last meeting. The interdisciplinary intervention is carried out in a collaboration of qualified personnel from The Norwegian labour and welfare service (NAV) and qualified health personnel from the hospital department of rehabilitation medicine.
The main hypothesis is that this interdisciplinary health and welfare intervention at the workplace reduces sick leave and improves mastering of common health problems more efficiently than a conventional welfare intervention. Conventional workplace measures are given by personnel of NAV workplace service without specialist healthcare involvement, focusing mainly on work inclusion and psychosocial work environment. There are several types of interventions available and they will be customized to the workplace. This means that the control intervention is not standardized and will be varying according to the workplaces' demands.
Participating workplaces are recruited through NAV's conventional contact with workplaces based on an analysis of the workplaces' needs. In the workplaces or workplace units that are interested in participating in the project, the following will be distributed to all staff- including leaders- through the employers' email-list: Information about the project, the informed consent-form and a link to the first electronic questionnaire (Q1). The electronic questionnaire portal is open to answers for two weeks after the initial email. After this time period, the workplaces are randomized to either Health in work or control intervention. A one year intervention period follows as described above. The questionnaire is repeated 12 months (Q2) and 24 months (Q3) after randomization. Q1-3 include the same questions regarding health complaints, health mastering, health related quality of life, and work environment.
Work participation will be assessed at the unit level by data from the employers' sickness absence registers that include both self- and physician-certified sickness absence. Physician-certified sickness absence at the individual level will be gathered from the National register of sickness absence over a four year period from 2 years before randomization to 2 years after. Individual sickness absence will also be assessed by self-report from the questionnaires, considering the last three months prior to the questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for workplaces/workplace units:
- •minimum 8 employees
- •accessible data on sickness absence (both self- and physician-certified) in the workplace/workplace unit for the past two years prior to inclusion
- •Inclusion Criteria for the individual employees:
- •all staff employed > 20% in the participating workplaces/workplace units
- •Norwegian-speaking
排除标准
- •for workplaces/workplace units:
- •ongoing profound reorganisation at the workplace/workplace unit (>20% change of employees within workplace unit)
- •Exclusion Criteria for the individual employees:
结局指标
主要结局
Change in overall sickness absence rates (self- and physician-certified) at the workplace (unit level)
时间窗: Time period 24 months prior to randomization compared to the time period 12-24 months after randomization
Sickness absence data from workplace-registers; Difference-in-difference analyses of sickness absence within and between intervention and control group (% of planned workdays).
Change in health-related quality of life (HRQoL) by EQ-5D-5L utility value, including EQ-VAS score
时间窗: Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization
Difference-in-difference analyses of HRQoL within and between intervention and control groups by use of EQ-5D/EQ-VAS.The EuroQol descriptive system EQ-5D-5L describes health along five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression). Participants rate each dimension along five severity levels from no problems (1) to extreme problems (5).The resulting combination (5 to the power of 5 = 3,125 possible combinations) is attached a utility value based on a national value set on a scale from 1(best health) to a 0(or even lower) for worst health.A Norwegian value set is currently being developed.The EQ-VAS (EuroQol vertical visual analogue scale;0 as worst,100 as best possible score) is an integral part that has to be included when using the EQ-5D questionnaire.It offers important, complementary information on respondents' valuations of their HRQoL that are not necessarily captured by use of the 5 dimensional descriptive part of this instrument.
Health-economic analyses
时间窗: Time period 24 months prior to randomization through 24 months after randomization
Cost-effectiveness analysis based on primary outcome 3 and cost-benefit analyses based on primary outcome 1 and 2. Comparing the intervention arms in terms of incremental costs based on direct- and indirect costs related to interventions throughout the intervention period.
Change in healthcare utilization
时间窗: Time period 24 months prior to randomization compared to the time period 12-24 months after randomization
Difference-in-difference analyses of health service refunds from National register of control and health service refunds (KUHR database, Helsedirektoratet) and Norwegian Patient Register (NPR, Helsedirektoratet) within and between intervention and control group.
次要结局
- Change in social support from colleagues by NDSS-16 score(Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization)
- Change in job satisfaction by GJS score(Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization)
- Change in health anxiety by Whitheley index score(Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization; comparison with Tromsø Study 7)
- Change in self-certified sickness absence rates (individual level)(Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization)
- Change in psychosocial work environment by Demand-Control-Support-Questionnaire score(Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization)
- Change in subjective health complaints by SHC score(Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization)
- Change in physician-certified sickness absence rates (individual level)(Time period 24 months prior to randomization compared to the time period 12-24 months after randomization)
- Change in Satisfaction of life by SWLS score(Enrollment (Q1) to 12 months (Q2) and 24 months (Q3) after randomization)
研究者
Anje Höper, MD/PhD
Principal investigator
University Hospital of North Norway